{"id":100280,"date":"2018-11-17T09:32:00","date_gmt":"2018-11-17T09:32:00","guid":{"rendered":"https:\/\/www.bnreport.com\/teaching-big-pharma-to-share-9\/"},"modified":"2018-11-17T09:32:00","modified_gmt":"2018-11-17T09:32:00","slug":"teaching-big-pharma-to-share-9","status":"publish","type":"post","link":"https:\/\/www.bnreport.com\/en\/teaching-big-pharma-to-share-9\/","title":{"rendered":"Teaching Big Pharma to share"},"content":{"rendered":"

This article is part of the Global Policy Lab: Decoding Cancer<\/a>. <\/em><\/p>\n

Researchers want to save the pharmaceutical industry time and money on clinical trials. But that means teaching companies to work together and convincing them to pool patient data, benefiting not just themselves but also their competitors.<\/p>\n

Its not an easy sell.<\/p>\n

\u201cIn the vast majority of cases, the company wants to be in control,\u201d said Denis Lacombe, chief of the European Organisation for Research and Treatment of Cancer.<\/p>\n

Lacombe is basically in a race against Big Pharma to build a public biological database before companies create their own private ones.<\/p>\n

The stakes, for patients, are high.<\/p>\n

Innovations in so-called precision medicine, in which treatments are tailored to individuals, has made patient data critically important. The more it is walled off in corporate troves, some cancer experts like Lacombe warn, the more the potential of using big data is undermined and the harder it becomes for patients to find relevant experimental treatments.<\/p>\n

EORTCs SPECTA platform<\/a> is a collection of genomic and other biological and clinical data. When a new treatment is available to be tested, the data can be searched to identify patients who could participate.<\/p>\n

Thats something that will be increasingly important as personalized medicine drives pharmaceutical companies \u201cto search for specific patients with specific [genetic] alterations,\u201d Lacombe said.<\/p>\n

That should be an opportunity for the pharma industry, said Lacombe. But it hasnt worked out that way.<\/p>\n

<\/p>\n

There are signs the industry is slowly coming around | Daniel Mihailescu\/AFP via Getty Images<\/p>\n

The industrys been slow to engage with SPECTA. Lacombe is concerned that instead, companies are starting to collect peoples genomic data on their own, without having a particular treatment or trial in mind.<\/p>\n

\u201cThere is a risk that the commercial sector will develop a \u2026 parallel route to access DNA,\u201d he said. Its \u201csuboptimal, if not unethical, that companies collect biological data and put it in a commercial silo.\u201d<\/p>\n

The EORTC isnt the only one trying to collect patient data.<\/p>\n

A parallel effort with a more utopian vision is based in the neutral Alpine haven of Switzerland. MIDATA<\/a> cites the philosopher John Rawls and his idea of \u201cProperty-Owning Democracy<\/a>\u201d in its promotional material. Its founder, Ernst Hafen, predicts that it could make even more money than Google or Facebook \u2014 though it would all be reinvested for the good of society.<\/p>\n

People who contribute personal information to MIDATA \u2014 whether its their genome or smartphone steps log \u2014 would remain the owners of their personal info and get to sign off on how its used. Theyd also become shareholders in MIDATA, able to vote on how it conducts business and spends its profits \u2014 earned in part by pharma companies who pay to recruit study participants.<\/p>\n

MIDATA is starting slowly, with some academic partnerships and some companies interested in how patients are faring with their migraine and multiple sclerosis drugs. But Hafen insists that MIDATA is the future, \u201ca citizen-empowered way of changing the way science is done.\u201d<\/p>\n

\n

Companies are deeply resistant to the idea of having their new idea compared (possibly unfavorably) to someone elses.<\/p>\n<\/blockquote>\n

If patient data is to be collected in public data bases, citizens might have to do the powering. But there are signs the industry is slowly coming around.<\/p>\n

Signs point to the pharma industry increasingly being open to sharing data and cooperating on trials, but theyre not eager to talk about it publicly yet. Requests for comment from both the European Federation of Pharmaceutical Industries, the sectors Brussels lobby, and individual companies yielded no one willing to discuss these new initiatives.<\/p>\n

Collaboration has never been the pharmaceutical industrys strong suit. While industries like aviation and semiconductors have been working together for decades, \u201cthe pharmaceutical industry has been lagging,\u201d said Dalvir Gill, CEO of TransCelerate BioPharma<\/a>, a nonprofit initiative trying to change that.<\/p>\n

Over the past seven years, TransCelerate has looked for ways to coordinate clinical trials. They have created a common set of forms<\/a> for different companies trials. It also created a network for companies to procure comparable drugs<\/a> from each other directly for use in trials, rather than having to buy the longer-standing treatment from third parties to test against a new drug.<\/p>\n

Ten companies signed on to TransCelerate initially, up to 19 now. Its required companies to change their mindset, Gill said.<\/p>\n

<\/p>\n

Vials containing biological samples at the Cancer Research U.K. Institute in Cambridge | Dan Kitwood via Getty Images<\/p>\n

Theres a \u201cvast amount of work that happens in the development of drugs that is not competitive,\u201d Gill said. \u201cThe R&D people get it,\u201d he added, but in the commercial divisions of a company, \u201ctheres a lot more convincing that needs to happen there.\u201d<\/p>\n

Regulators also need convincing, Gill noted \u2014 when companies cooperate, it raises a different set of eyebrows.<\/p>\n

\u201cOur biggest barriers are typically not running afoul of antitrust,\u201d Gill said. \u201cWhenever you have 19 companies in a room doing something,\u201d its going to draw scrutiny.<\/p>\n

With lots of new cancer drugs coming out for increasingly narrow subsets of cancer patients, so-called platform trials \u2014 in which multiple new drugs are tested at once \u2014 are seen as a key way to speed up the process and avoid duplication.<\/p>\n

But companies are deeply resistant to the idea of having their new idea compared (possibly unfavorably) to someone elses.<\/p>\n

<\/p>\n

Surgical oncologists treat a breast cancer patient in Marseille, southeastern France | Anne-Christine Poujoulat\/AFP via Getty Images<\/p>\n

The I-SPY 2<\/a> trial for breast cancer, a nonprofit platform trial that has resulted in three drugs winning approval, shows drugs can be tested at the same time without being pitted against each other. Instead theyre tested against the existing standard of care.<\/p>\n

Brian Alexander, a Harvard radiation oncologist preparing to launch a platform trial for brain tumors called GBM AGILE, said that the precedent has made it easier for him to convince companies to let him test their drugs.<\/p>\n

\u201cThey werent as worried anymore because once you see two New England Journal [of Medicine] papers in the same edition, both coming from arms from I-SPY 2, and theyre not compar[ed to] each other\u2026 then [drugmakers] were like, Oh, ok, that isnt that much of an issue,\u201d Alexander said.<\/p>\n

Hes expecting to announce the first drug to be tested in the new GBM AGILE trial<\/a> next week, but he said that overcoming companies fear of sacrificing control remains a major challenge.<\/p>\n

\u201cTo feel like theyre turning over the late stage development of an asset to this other entity \u2014 thats a bit of a tough sell,\u201d Alexander said.<\/p>\n

The POLITICO Global Policy Lab<\/a> is a collaborative journalism project seeking solutions to pressing policy problems. Join the community<\/a>. <\/em><\/p>\n

Read this next: Hundreds of thousands march to celebrate Polish independence<\/a><\/em><\/h2>\n

Original Article<\/a><\/p>\n

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<\/a><\/h5>\n","protected":false},"excerpt":{"rendered":"

This article is part of the Global Policy Lab: Decoding Cancer. <\/p>\n

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